FY 2025 - FDA Medical Device Registration Fees

FDA Medical Device Establishment registration fee for the year 2025 is USD 9,280. FDA fiscal year 2025 starts on October 1, 2024, and ends on September 30, 2025. The annual establishment registration fee must be paid between October 1, 2024, and December 31, 2024. The establishment registration fee is not eligible for a reduced small business fee.

FDA Registration Fees 2025

FDA Fee for Medical Device Registration and Applications for Fiscal Year 2025

Type of Registration / Application

Standard Fees

Small Business Fee

Medical Device Establishment Registration

$9,280

$9,280

FDA 510(k) Submission

$24,335

$6,084

FDA 513(g) Submission

$7,301

$3,650

FDA PMA, PDP, PMR, BLA Submission

$540,783

$135,196

De Novo Classification Request

$162,235

$40,559

Panel-track Supplement

$432,626

$108,157

180-Day Supplement

$81,117

$20,279

Real-Time Supplement

$37,855

$9,464

BLA Efficacy Supplement

$540,783

$135,196

30-Day Notice

$8,653

$4,326

Premarket report

$540,783

$135,196

Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)

$18,927

$4,732

FDA defines a small business as a business with $100 million or less in gross receipts or sales, including receipts or sales from its affiliates. In addition, if a small business has gross receipts or sales of $30 million or less, it is eligible to have the fee waived for its first PMA, PDP, PMR, or BLA.

Quick links